The Regulation of Recombinant Bovine Growth Hormone (Rbgh) in the United States and Canada, 1982-1998
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Bell & Howell Information and Learning 300 North Zeeb Road, Ann Arbor, MI 48106-1346 USA Science and Social Context: The regulation of recombinant bovine growth hormone (rbGH) in the United States and Canada, 1982-1998 Lisa Nicole Mills A thesis submitted in conformity with the requirements for the degree of Doctor of Philosophy Graduate Department of Political Science University of Toronto O Copyright by Lisa Nicole MiUs 1999 National Library Bibliotheque nationale du Canada Acquisitions and Acquisitions et Bibliographic Services services bibliographiques 395 Wellington Street 395. rue Wellington "Ottawa ON KIA ON4 Otbwa ON KIA ON4 Canada Canada The author has granted a non- L'auteur a accorde me licence non exclusive licence allowing the exclusive permettant a la National Library of Canada to Bibliotheque nationale du Canada de reproduce, loan, distribute or sell reproduire, preter, distriiuer ou copies of this thesis in microform, vendre des copies de cette these sous paper or electronic formats. la fome de microfichelfilm, de reproduction sur papier ou su.format electronique. The author retains ownership of the L'auteur conserve la propriete du copyright in this thesis. Neither the droit d'auteur qui protege cette these. thesis nor substantial extracts fkom it Ni la these ni des extraits substantiels may be printed or otherwise de celle-ci ne doivent Etre imprimes reproduced without the author7s ou autrement reproduits sans son permission. autorisation. Abstract Science and social context: The regulation of recombinant bovine growth hormone (rbGH) in the United States and Canada, 1982-199s Doctor of PhiIosophy 1999 Lisa Nicole Milk Graduate Department of Political Science University of Toronto This dissertation explores the relationship between science arid public policy in the case of recombinant bovine growth hormone (rbGH), a geneticallyengineered drug which increases milk yield in cows. The product was approved by the United States Food and Drug Administration in 1993; it has not been approved in Canada. In both countries, the debate over the product's safety has been intensely controversial. The dissertation argues that problems in the relationship between science and policy arise at the point when judgements are made about the scientific evidence. Although there was agreement about the scientific evidence across institutions, the interpretation of that evidence diverged depending on the context from which it was viewed, The dissertation uses Helen Longino's concept of contextual empiricism to explain the varying outcomes in different settings. Scientists' conception of the kind of evidence required to make a judgement about product safety, and their interpretation of that evidence, was guided by the background assumptions they brought to it. These assumptions were context-dependent, however, with the resuIt that policy responses differed between the U.S. and Canada, and the assumptions themselves were the subject of conflict in both countries. The difference in the U.SJCanadian response is the most obvious example of a contrast in the assessment of the drug's introduction. The dissertation also examines differing interpretations between the academic, corporate, and regulatory settings in order to elucidate the science and policy relationship. The dissertation contributes to the literature on science and public policy by examining the process by which scientists make sense of empirical evidence. It argues for the relevance of the concept of contextual empiricism for understanding the science-policy relationship. It has attempted a theoretical synthesis, drawing on concepts from the history and philosophy of science and political economy to better understand this relationship. The concept of contextual empiricism accounts for both the degree of consensus about the evidence, and the degree of divergence in its interpretation, between institutions and jurisdictions. Acknowledgements I would like to thank my supervisor, Professor David Wok, for his support and encouragement, and the members of my committee, especially Professor Liora Salter. I also wish to acknowledge all of the individuals whom I interviewed as part of the thesis research, particularly officials at the U.S. Food and Drug Administration, who were generous with their time both during the interviews and in subsequent cof~llllunications. The following institutions and individuals also made important contributions to the completion of the thesis: the Toronto Food PoLicy Council gave me access to its library; Dr. Alison Weir tutored me in statistics; Dr. Magi Abdul-Masih assisted me with understanding concepts in biochemistry; and Patricia Fleck gave valuable assistance with the typing of the bibliography and checking of interview quotes. The thesis was written with financial support from the University of Toronto Open Fellowship, and a School of Graduate Studies Travel Grant- Many thanks to my family and friends for their support, particularly the Loretto Sisters, Extended Community, Leadership Team and staff, whose kindness and generosity have sustained me over the last five years; and to Leslie Crawford; Catherine and Peggy Lathwell; Katie Isbester; Mary-Beth Raddon; Joe Murray, and especially Deborah C lipperton. Table of Contents .0 Abstract.......................................................................... 11 Acknowledgements ................................................................... iv Acronyms ...................................................................... VIII Chapter One: Introduction I . Introduction. ....................................................... 1 2 . Literature review .................................................................... 8 2 1. Science and pubIic policy literature.......................................... ..... 8 2.2. Philosophy of Science Literature ............ ... ............................. 14 2.3. Political economy of agriculture literature ................ .... ...... 18 3 . Methodology .......................................................................23 4- Chapter Outline .................................................................... 26 Chapter Two: The economic context: The political economy of agricultural biotechnology Introduction .............................................................. 28 Regulatory Changes and the Commercialization of Genetic Research ......29 Commercialization and biotechnology ........................................ 31 'A 95-year old stamp company": Monsanto and biotechnology..................................................................... -36 Monsanto and rbGH ............... ,.. ............................................ 44 University Scientists and rbGH research ....................................... 53 Conclusion ......... .., ..................................................*..........-58 Chapter Three: The U.S. context Introduction ........................................................................ 60 The U.S. experience . overview .............................................. 60 The U.S. Regulatory System ............. ... ............................... 68 Biotechnology: The Regulatory Environment in the 1980s.............. .... 68 Animal Drug Laws and the rbGH review ................. .... ....... 71 Milk labelling ..................................................................... 87 Approval ........................................................................... -91 Conclusion ..................... .,,. ............................................ -98 Chapter Six Conclusion 1. The interpretation the evidence.,.*.*.*......*......... --....-. ....*......-209 2. Conclusion.. ........................ .............................--..------.--.---AA 730 References..,.......-.-...,. .................................................. ..233 Interviews...................................................................... 263 vii Acronyms CAC - Codex Alimentarius Commission CDC - Canadian Dairy Commission BVD - Bureau of Veterinary Drugs (Canada) CEPA - Canadian Environmental Protection Act CMSMC - Canadian Milk Supply Management Cornrnittee CVM - Center for Veterinary Medicine (US.) FA0 - United Nations Food and Agriculture Organization FDA - Food and Drug Administration FFDCA - Federal Food, Drug, and Cosmetic